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The Aperio GT 450 DX is an automated digital slide creation and viewing system. The Aperio GT 450 DX is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The Aperio GT 450 DX is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy.

Aperio GT 450 DX is comprised of the Aperio GT 450 DX scanner, which generates images in the Digital Imaging and Communications in Medicine (DICOM) and in the ScanScope Virtual Slide (SVS) file formats, the Aperio WebViewer DX viewer, and the displays. The Aperio GT450 DX is intended to be used with the interoperable components specified in Table 1.

The Aperio GT 450 DX is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using the Aperio GT 450 DX.

The Aperio GT 450 DX is a Whole Slide Imaging (WSI) system, including image acquisition and image viewing components.

Aperio GT 450 DX is a WSI system comprised of an image acquisition subsystem known as the Aperio GT 450 DX scanner and Aperio WebViewer DX image viewing software which is accessed from a workstation and a display.

Image Acquisition Subsystem: The image acquisition subsystem of the Aperio GT 450 DX captures the information from surgical pathology glass slides prepared from FFPE tissue and saves it as a high-resolution digital image file. This subsystem is comprised of the Aperio GT 450 DX scanner and corresponding scanner configuration software, Aperio GT 450 Scanner Administration Manager DX (SAM DX).

The Aperio GT 450 DX scanner is a semi-automated benchtop brightfield WSI scanner that can achieve a scan speed of 32 seconds at the 40x scanning magnification for a 15 mm x 15 mm area. The scanner supports continuous glass-slide loading (Up to 15 racks with a total of 450-slide capacity), priority rack scanning, and automated image quality checks during image acquisition. The Aperio GT 450 DX scanner can be used with Leica Biosystems Imaging, Inc .--manufactured slide racks (Product No. 23RACKGT450) and other supported slide racks (e.g., Prisma® 20-slide basket from Sakura Finetek USA, Inc). The Aperio GT 450 DX scanner detects the racks once loaded in the scanner and scans the slides automatically. Users operate the scanner via a touchscreen interface.

The Aperio GT 450 DX scanner can save digital images in a unique Aperio ScanScope Virtual Slide (SVS) image format or Digital Imaging and Communications in Medicine (DICOM) image format. The digital images are sent to end-user-provided image storage attached to the scanner's local network, where they can be cataloged in image storage software (non-medical device, external to the WSI), including Image Management System (IMS), such as Aperio eSlide Manager, or a Picture Archiving and Communication System (PACS), such as Sectra PACS software.

Aperio GT 450 SAM DX is centralized scanner management software external to the connected scanner(s). This software application enables IT implementation, including configuration, monitoring, and service access of multiple scanners from a single desktop client location. Aperio GT 450 SAM DX is installed on a customer-provided server that resides on the same network as the scanner(s) for image management.

Image Viewing Subsystem: The image viewing subsystem of the WSI device displays the digital images to the human reader. This subsystem comprises Aperio WebViewer DX image viewing software, a workstation PC, and monitor(s). Both the workstation and display are procured by the customer from commercial distributors and qualified for in vitro diagnostic use by Leica Biosystems Imaging, Inc. The Aperio WebViewer DX software is a web-based image viewer that enables users to perform Quality Control of images and to review and annotate digital images for routine diagnosis. The Aperio WebViewer DX also incorporates monitor display image validation checks, which provide the user with the ability to ensure the digital slide images are displayed as intended on their monitor, and that browser updates have not inadvertently affected the image display quality. Aperio WebViewer DX is installed on a server and accessed from an IMS (e.g., Aperio eSlide Manager) or a customer's Laboratory Information System (LIS) using compatible browsers.

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for Aperio GT 450 DX

1. Table of Acceptance Criteria and Reported Device Performance:

Note: WSIR = Whole Slide Image Review; MSR = Light Microscope Slide Review

2. Sample Size for Test Set and Data Provenance:

• Clinical Accuracy Study (Full Cohort):

  • WSIR Diagnosis: 3549 cases.
  • MSR Diagnosis: 3631 cases.
  • The "Full Cohort" combines local and remote cohorts, suggesting data collection may have occurred across multiple sites or access methods. The country of origin is not explicitly stated, but clinical studies for FDA submissions typically involve well-regulated clinical environments, often in the US. The study appears to be retrospective as it compares diagnoses from WSIR and MSR against "reference diagnoses" (original sign-out pathologic diagnoses), suggesting these reference diagnoses were pre-existing.

• Precision Study: The sample sizes vary by substudy:

  • Intra-System Precision: 759 comparison pairs (737 pairwise agreements).
  • Inter-System/Site Precision: 759 comparison pairs (731 pairwise agreements).
  • Intra-Pathologist Precision: 2277 comparison pairs (2129 pairwise agreements).
  • Inter-Pathologist Precision: 2277 comparison pairs (2089 pairwise agreements).
  • The origin of the data for the precision study is not specified but involves "three independent systems at three different sites" for inter-system/site precision. The nature of the "cases" for precision implies pathologists reviewing slides/images, potentially from similar sources as the accuracy study.

3. Number of Experts and Qualifications for Ground Truth:

• The text refers to "the pathologists" in the context of the device's intended use and the "original sign-out pathologic diagnosis" as the reference diagnosis (ground truth) for the clinical accuracy study.
• The number of pathologists establishing the original sign-out diagnoses for the entire cohort of slides is not explicitly stated.
• The qualifications implied are "qualified pathologist" to ensure the validity of interpretation. Specific years of experience are not provided.
• For the precision study, it refers to "3 pathologists" in the intra- and inter-pathologist precision substudy, but their specific qualifications (e.g., years of experience) are not listed.

4. Adjudication Method for the Test Set:

• The clinical accuracy study established "reference diagnoses" as the "original sign-out pathologic diagnosis." This suggests that the ground truth was based on a primary diagnostic process, which may or may not inherently involve an adjudication method like 2+1 or 3+1 during its initial establishment. The document does not explicitly describe an adjudication method used to establish this "reference diagnosis" or the ground truth for the test set. It implies a single, established diagnostic truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Yes, a comparative effectiveness study was done. The clinical accuracy study compared diagnoses made using the Aperio GT 450 DX (WSIR) against traditional light microscope slide review (MSR) diagnoses, both relative to a reference diagnosis. This involved multiple readers (pathologists) examining multiple cases.
• Effect Size of Human Readers Improvement with AI vs. without AI Assistance: This study does not describe an AI assistance scenario. The Aperio GT 450 DX is a Whole Slide Imaging (WSI) system for digital review of slides, not an AI diagnostic aid. It enables pathologists to interpret digital images, which is compared to their interpretation using a physical microscope. Therefore, there is no "AI assistance" component described for improving human reader performance. The study focuses on the equivalence of digital review to traditional microscopy.

6. Standalone (Algorithm Only) Performance:

• No, a standalone (algorithm only) performance study was not described. The Aperio GT 450 DX is a system intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images. Its performance is evaluated with a human in the loop, comparing the pathologist's interpretation of digital images to their interpretation of glass slides. The device itself does not provide an automated diagnosis.

7. Type of Ground Truth Used:

• The ground truth for the clinical accuracy study was the "original sign-out pathologic diagnosis." This implies an expert consensus or established diagnostic conclusion based on standard pathological procedures. Other types like pathology reports, outcomes data, or a specific gold standard adjudication were not explicitly detailed beyond being the "original sign-out."

8. Sample Size for the Training Set:

• The document does not provide information regarding a specific training set or its sample size. This is a WSI system, not a device with a machine learning component that requires a labeled training set for its core function of image acquisition and display. The "tissue detection algorithms" are mentioned as part of the technical studies (whole slide tissue coverage), but details on how these were trained are not provided.

9. How the Ground Truth for the Training Set was Established:

• Since a training set and its sample size are not mentioned for the core function of the device, the method for establishing its ground truth is not provided in this document.

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The Aperio AT2 DX System is an automated digital slide creation and viewing system. The Aperio AT2 DX System is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The Aperio AT2 DX System is not use with frozen section, cytology, or non-FFPE hematopathology specimens.

The Aperio AT2 DX System is composed of the Aperio AT2 DX scanner, the ImageScope DX review application and Display. The Aperio AT2 DX System is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the interpretation of images obtained using the Aperio AT2 DX System.

The Aperio AT2 DX System is an automated digital slide creation and viewing system. The system is comprised of an Aperio AT2 DX scanner instrument and a Viewing Workstation with a computer and a calibrated monitor executing ImageScope DX viewer software. The system capabilities include digitizing microscope slides at diagnostic resolution, retrieving and displaying digital slides, including support for remote intra-net access over computer networks, providing tools for annotating digital slides, entering data associated with digital slides and displaying the scanned slide images for primary diagnoses by Pathologists.

Here's a breakdown of the acceptance criteria and study details for the Aperio AT2 DX System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The text doesn't explicitly state the total number of unique cases used in the clinical study. However, we can infer some details from the precision studies:

• Intra-System Study: "Pairwise Agreements" and "Comparison Pairs" numbers are provided for 3 systems, ranging from 193-201 agreements out of 201-204 pairs per system. This suggests hundreds of slides were used.
• Inter-System/Site Study: "Pairwise Agreements" and "Comparison Pairs" numbers are provided for 3 system comparisons, ranging from 193-195 agreements out of 202 pairs per comparison.
• Within- and Between-Pathologist Study: "Pairwise Agreements" and "Comparison Pairs" numbers are provided for 3 pathologists and 3 pathologist comparisons, ranging from 561-579 agreements out of 606-1818 pairs.

The total reads for the major discrepancy analysis were 7509 for WSIRD and 7522 for MSRD. This suggests a significantly larger number of samples or multiple reads per sample.

• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the study involved "three independent systems at three different sites" for the Inter-System/Site Precision study, implying a multi-site prospective clinical study for data collection. The use of "original sign-out pathologic diagnosis" as the gold standard implies retrospective access to patient records for comparison.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Ground Truth Experts: The text states that "the original sign-out pathologic diagnosis" was used as the gold standard reference diagnosis. This implies that the ground truth was established by multiple qualified pathologists in a routine clinical diagnostic setting as part of their standard practice.
• Qualifications of Experts: The experts are described as "qualified pathologists" in the context of their ability to make clinically relevant decisions using conventional microscopes. Specific details like years of experience are not provided.

4. Adjudication Method for the Test Set

The text refers to the "original sign-out pathologic diagnosis" as the gold standard. This suggests that the ground truth was based on the final, adjudicated diagnosis made in a clinical setting, which typically involves consensus or final sign-out by a senior pathologist. There is no mention of a specific adjudication process (e.g., 2+1, 3+1) specifically for the test set ground truth if it differed from the original sign-out. The comparison was against this pre-existing ground truth.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Yes, a form of comparative effectiveness study was done. The study directly compared "Whole Slide Image Review (WSIR) diagnoses" (AI-assisted, as the device is for creating and viewing digital slides) against "traditional light microscope slide review (MSR) diagnoses."

• Effect Size / Improvement: The study focused on non-inferiority rather than explicit improvement of human readers with AI assistance compared to without AI assistance. The primary acceptance criteria were about ensuring digital review was not significantly worse than traditional microscope review.
  • The difference in overall major discrepancy rates between WSIR and MSR was 0.44%, with a 95% CI of (-0.15%, 1.03%). This indicates that the WSIR diagnoses were statistically non-inferior to MSR diagnoses regarding major discrepancies. The upper bound of 1.03% implies that the WSIR method was not substantially worse than MSR (as it was well below the 4% acceptance criterion).

6. Standalone Performance Study

No, a standalone (algorithm only without human-in-the-loop performance) study was not explicitly mentioned or performed as part of the primary clinical evaluation. The device is described as an "aid to the pathologist to review and interpret digital pathology slides," meaning it's intended for human-in-the-loop use. The performance evaluation directly involved pathologists using the system (WSIR diagnoses).

7. Type of Ground Truth Used (Test Set)

The primary ground truth used for evaluating accuracy was the "original sign-out pathologic diagnosis," which represents expert consensus or final clinical pathology diagnosis.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. The descriptions focus on the performance evaluation (test set) for regulatory clearance.

9. How the Ground Truth for the Training Set Was Established

As the training set information is not provided, how its ground truth was established is not detailed in this document.

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The Aperio ePathology eIHC IVD System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape.

The IHC HER2 Image Analysis application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER2/neu (c-erbB-2) in formalin-fixed, paraffin-embedded neoplastic tissue.

The IHC HER2 Image Analysis application is intended for use as an accessory to the Dako HercepTest™ to aid in the detection and semi-quantitative measurement of Her2/neu (c-erbB-2) in formalin-fixed, paraffin-embedded neoplastic tissue. When used with the Dako HercepTest™, it is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN®(Trastuzumab) treatment is being considered.

The IHC ER Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitative measurement of ER (Estrogen Receptor) in formalin-fixed paraffin-embedded neoplastic tissue.

The IHC PR Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitation measurement of PR (Progesterone Receptor) in formalin-fixed, paraffin-embedded neoplastic tissue.

lt is indicated for use as an aid in the management, prognosis, and prediction of therapy outcomes of breast cancer.

The Aperio ePathology eIHC IVD System ("System") is an automated digital slide creation, management, viewing and analysis system. The Aperio ePathology eIHC IVD System components consist of an automated digital microscope slide scanner, computer, color monitor, keyboard and digital pathology information management software. The system capabilities include digitizing microscope slides at high resolution, storing and managing the resulting digital slide images, retrieving and displaying digital slides, including support for remote access over wide-area networks, providing tools for annotating digital slides and entering and editing data associated with digital slides, and tools for image analysis of digital slides. Image analysis capabilities include the ability to quantify characteristics useful to Pathologists, such as measuring and scoring immunohistochemical stains applied to histology specimens, including the Dako HerceptTest™, Dako ER/PR, which reveal the presence of proteins such as Human Epidermal growth factor Receptor 2 (HER2), ER (Estrogen Receptor) protein and PR (Progesterone Receptor) protein expression.

Below summarizes the acceptance criteria and study information for the Aperio ePathology eIHC IVD System, specifically for its HER2, ER, and PR Image Analysis applications.

1. Table of Acceptance Criteria and Reported Device Performance

For IHC HER2 Image Analysis:

For IHC ER and PR Image Analysis:

2. Sample Size and Data Provenance for Test Set

• Sample Size: Not explicitly stated for either HER2 or ER/PR. The document mentions "slides represented the range of HER2 scores (0, 1+, 2+ and 3+)" and "slides represented the range of ER and PR scores that are observed clinically."
• Data Provenance: The samples were "Paraffin embedded breast tissue slides prepared with the appropriate Dako HER2 IHC test kit" and "Paraffin embedded breast tissue slides prepared with the appropriate Dako ER and PR IHC test kits." The origin (e.g., country) is not specified. The studies were internal system performance tests, implying a retrospective nature where pre-existing clinical samples were used.

3. Number of Experts and Qualifications for Ground Truth

• The document states that the HER2, ER, and PR scores obtained from the updated ScanScope systems were "evaluated for concordance with the scores obtained from the predicate device." This suggests the predicate device's scores served as the reference for comparison, rather than human experts directly establishing ground truth for the test set in these specific performance studies.
• No information is provided about the number or qualifications of experts directly establishing ground truth for the test set used in the system performance testing. The predicate device's output was the reference.

4. Adjudication Method

• Not applicable as the comparison was against the predicate device's scores, not human expert consensus requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. The studies described were system-level performance tests evaluating the updated ScanScope instruments against a predicate device.
• Therefore, no effect size of human readers improving with AI vs. without AI assistance is provided. The device is intended as an "adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist."

6. Standalone Performance Study

• Yes, a standalone study (algorithm-only performance) was conducted. The "System Performance Testing" described for both HER2 and ER/PR evaluated the "accuracy of the HER2 image analysis algorithm on the updated ScanScope instruments" and "accuracy of the ER and PR image analysis algorithms on the updated ScanScope instruments," respectively, by comparing their output against the predicate device's scores.

7. Type of Ground Truth Used

• For the system performance testing, the ground truth used was the scores obtained from the legally marketed predicate device (ScanScope XT). The updated ScanScope models' results were evaluated for concordance with the predicate device's scores.

8. Sample Size for the Training Set

• The document does not provide information regarding the sample size specifically used for training the image analysis algorithms. The described studies are performance evaluations of the already developed algorithms.

9. How Ground Truth for Training Set was Established

• The document does not provide information on how the ground truth for the training set was established. The focus of this submission is on the direct comparison of the updated devices' performance to the predicate device.

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